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The ALLY™ Adaptive Cataract Treatment System is an ophthalmic surgical laser indicated for use:

• · in the creation of an anterior capsulotomy.
• · in patients undergoing surgery requiring laser-assisted fragmentation of the cataractous lens.
• · in the creation of full and partial thickness single-plane and multi-plane arc cuts/incisions in the cornea.

The ALLY" Adaptive Cataract Treatment System (ALLY" System) is a medical device intended for use in ophthalmic surgery. The ALL Y™ System brings the precision of femtosecond laser to the cataract procedure. The ALL Y™ System allows for an initial femtosecond laser procedure using a dual-pulse-width laser used to cut a precision capsulotomy in the anterior lens capsule; laser-assisted fragmentation of the cataractous lens for removal during cataract surgery; and full and partial thickness single-plane and multi-plane arc cuts/incisions in the cornea. Each of which may be performed either individually or consecutively during the same procedure.

The provided text describes the LENSAR ALLY™ Adaptive Cataract Treatment System and its substantial equivalence to a predicate device, the LENSAR Laser System – fs 3D (LLS-fs 3D). However, it does not contain a specific study demonstrating performance against acceptance criteria in the way typically required for AI/ML device evaluations (e.g., diagnostic performance metrics like sensitivity, specificity, or AUC).

Instead, the document focuses on demonstrating that the ALLY™ System is substantially equivalent to its predicate device through non-clinical performance data, ensuring it meets safety and effectiveness requirements.

Here's an attempt to answer your questions based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria in the form of quantitative performance metrics (e.g., sensitivity, specificity, accuracy) for a specific task. Instead, it describes various non-clinical tests conducted to ensure the device's safety, effectiveness, and equivalence to the predicate. The "performance" here refers to meeting engineering and safety standards.

2. Sample Sizes and Data Provenance

• Test Set Sample Size: Not applicable in the context of diagnostic performance studies. The "test set" here refers to various samples used for non-clinical engineering and safety testing (e.g., material samples for biocompatibility, packaging samples for integrity). Specific sample sizes for each non-clinical test are not detailed in this summary.
• Data Provenance: The nature of the non-clinical tests implies that the data was generated specifically for the ALLY™ device during its development and testing phases. There is no mention of external, retrospective, or prospective patient data sets for performance evaluation in the diagnostic sense. The testing was conducted by LENSAR, Inc., likely in the US, as suggested by the FDA submission.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This submission focuses on engineering and safety validation, not on diagnostic performance or interpretation by human experts.

4. Adjudication Method

Not applicable. There is no mention of expert adjudication for ground truth for diagnostic or interpretative tasks.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted and is not mentioned in the document. The device is a surgical laser system, and the evaluation focuses on its technical performance and safety, not on improving human reader performance in interpreting medical images with AI assistance.

6. Standalone Performance Study (Algorithm Only)

No, a standalone algorithm-only performance study (in the context of AI/ML diagnostic or interpretative algorithms) was not explicitly conducted or described. The document describes the performance of the integrated ALLY™ system itself through various engineering and safety tests. While the system uses "automated precision" and "treatment planning tools for precision-guided laser treatments," the evaluation presented is not a standalone AI algorithm performance study in the typical sense of measuring diagnostic accuracy.

7. Type of Ground Truth Used

The "ground truth" for the various non-clinical tests would be the established engineering standards, safety regulations, and predetermined specifications that the device had to meet. For example:

• Eye Safety: ANSI Z-136.1:2014 standards.
• Biocompatibility: ISO 10993-1 standards.
• Sterile Device Packaging: ISTA 3A, ASTM F2096, ASTM F88 standards.
• EMC & Electrical Safety: ANSI/AAMI/IEC 60601-1-2:2014, ANSV/AAMI/ES 60601-1:2005 A1:2012 standards.
• Software: IEC 62304 standard and FDA guidance.

8. Sample Size for the Training Set

Not applicable. The document does not describe an AI/ML model that would require a distinct "training set" of data for diagnostic or interpretative learning. The "automated precision" and "treatment planning tools" are likely based on deterministic algorithms and calibrated parameters from engineering design, not deep learning from a large training dataset.

9. How the Ground Truth for the Training Set was Established

Not applicable, as no AI/ML training set is described.

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